iRadimed Corp 2025年季度报告

Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act). Yes☐No☒The registrant had12,715,109shares of common stock, par value $0.0001 per share, outstanding as of April 30, IRADIMED CORPORATION Table of Contents Signatures CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS Certain statements contained in thisQuarterly Report on Form10-Q for the quarter endedMarch31,2025 (this “Quarterly Report”) that are not historical facts may constitute forward-lookingstatements within the meaning of Section 27A of the Securities Act of 1933, as amended (the“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the“Exchange Act”) , and are intended to be covered by the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995. When used in this Quarterly Report the words “believe,”“anticipate,” “expect,” “may,” “will,” “assume,” “should,” “predict,” “could,” “would,” “intend,”“targets,” “estimates,” “projects,” “plans,” and “potential,” and other similar words and expressionsof the future, are intended to identify such forward-looking statements, but other statements not based ●our ability to receive 510(k)clearance for our products and product candidates,complete inspections conducted by the U.S. Food& Drug Administration (the “FDA”)or other regulatory bodies resulting in favorable outcomes, additional actions by or ●the timing and likelihood of regulatory approvals or clearances from the FDA or otherregulatory bodies and regulatory actions on our product candidates and product ●unexpected costs, expenses and diversion of management attention resulting fromactions or requests posed to us by the FDA or other regulatory bodies; ●failure to obtain and/or maintain regulatory approvals or clearances and comply withapplicable regulations; ●our primary reliance on a limited number of products; ●our ability to retain the continued service of our key professionals, includingkeymanagement, marketing and scientific personnel,and to identify, hire and retain suchadditional qualified professionals; ●our expectations regarding the sales and marketing of our products, product candidatesand services; ●our expectations regarding the integrity of our supply chain for our products;●the potential for adverse application of environmental, health and safety and other lawsand regulations of any jurisdiction on our operations;●our expectations for market acceptance of our new products;●the potential for our marketed products to be withdrawn due to recalls, patient adverseevents or deaths;●our ability to successfully prepare, file, prosecute, maintain, defend, including in casesof infringement, and enforce patent claims and other intellectual property rights on ourproducts;●our ability to identify and pursue development ofadditional products; ●the implementation of our business strategies;●the potential for exposure to product liability claims;●our financial performance expectations and interpretations thereof by securities analystsand investors;●our ability to compete in the development and marketing of our products and productcandidates with existing companies and new market entrants in our industry;●difficulties or delays in the development, production, manufacturing and marketing ofnew or existing products and services, including difficulties or delays associated withobtaining requisite regulatory approvals or clearances associated with those activities;●changes in laws and regulations or in the interpretation or application of laws orregulations, as well as possible failures to comply with applicable laws or regulations asa result of possible misinterpretations or misapplications;●cost-containment efforts of our customers, purchasing groups, third-party payers andgovernmental organizations;●costs associated with protecting our trade secrets and enforcing our patent, copyrightand trademark rights, and successful challenges to the validity of our patents, copyrightsor trademarks; Table of Contents ●unfavorable changes to the terms of key customer or supplier relationships;●weakening of economic conditions, or the anticipation thereof, that could adverselyaffect the level of demand for our products; These forward-looking statements involve a number of risks and uncertainties that couldcause actual results to differ materially from those suggested by the forward-looking statements.Forward-looking statements should, therefore, be considered in light of various factors, includingthose set forth under “Part I, Item 2. Management's Discussion and Analysis of Financial Conditionand Results of Operations,” “Part II, Item 1A. Risk Factors,” and elsewhere in this Quarterly Report,and under “Part I, Item 1A. Risk Factors” and “Part II, Item 7. Management's Discussion andAnalysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K forthe fiscal year ended December31,2024 (the “2024 Annual Rep